两种方法检测RA患者血清抗CCP抗体的结果比对分析

目的 比较酶联免疫吸附试验(ELISA)法和胶乳免疫比浊法检测血清抗环瓜氨酸肽(抗-CCP)抗体对RA患者的诊断价值和临床适用性。方法收集西安市风湿病研究所2014年12月～2015年2月期间住院患者的新鲜血清267份,另选陕西省血液中心健康献血员新鲜血清50例,分别用酶联免疫吸附试验(ELISA)法和胶乳免疫比浊法检测抗CCP抗体,评价两种方法结果的相关性及其对RA诊断的临床适用性。结果 ELISA和胶乳免疫比浊法的敏感度、特异度和诊断一致性分别为77.3%,86.8%,94.3%和76.2%,80.2%,77.9%; 两种方法比较Kappa值为0.756,二者具有一致性; 对两组数据进行χ²检验,χ²=1.85,P＞0.05,方法间比较差异无统计学显著性意义; ELISA和胶乳免疫比浊法ROC曲线下面积分别是0.876和0.832。结论 血清抗CCP抗体检测对RA患者具有一定的诊断价值,ELISA法和胶乳免疫比浊法检测抗CCP抗体具有一致性。两种方法学之间无统计学差异,胶乳免疫比浊法更适合于基层医疗机构的应用。

Comparison Analysis of the Results of Serum Anti CCP Antibody in Patients with RA by Two Methods

Objective To compare diagnosis value and the clinical application of enzyme linked immunosorbent assay(ELISA)method and the immune turbidimetric method detecting serum anti cyclic citrullinated peptide(CCP)antibody in patients with RA.Methods Collected freshserum specimen of 267 inpatients with RA in Rrheumatism Department of Xi'an Institute of Rheumatism from December 2014 to February 2015,and fresh serum specimen of 50 healthy blood donors from the Blood Center of Shaanxi Province respectively.Anti CCP antibody was detected by enzyme-linked immunosorbent assay(ELISA)method and the latex immunoturbidimetry assay.Evaluated the correlation of the results and clinical application to RA diagnosis.Results Sensitivity,specificity and diagnostic consistency of ELISA and latex immunoturbidimetry assay were 77.3%,86.8%,94.3% and 76.2%,80.2%,77.9% respectively.Compared two kinds of methods,the value of Kappa was 0.756,for having consistency.Through χ² test(χ²=1.85,P＞0.05),there was no significant difference between two methods.Area of ELISA and lateximmunoturbidimetry under the ROC curve were 0.876 and 0.832 respectively.Conclusion Detection of serum anti CCP antibody has diagnostic value inRA patients.The ELISA method and the latex immunoturbidimetry assay for detection of anti CCP antibodies had consistency.Two methods had no statistical difference,and the latex turbidimetric method is suitable for grassroots medical institutions.